MedTrace Logo

A Study to Gather Information About User Satisfaction in Women in Russia Who Take Estradiol Valerate/Dienogest

NCT04901377 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 255

Last updated 2023-09-18

No results posted yet for this study

Summary

Researchers want to learn more about user satisfaction in women in Russia who take estradiol valerate/ dienogest as a contraceptive in real conditions.

Estradiol valerate/ dienogest is a form of birth control. This is also known as a combined oral contraceptive (COC). Earlier studies showed that estradiol valerate/ dienogest has high level of protection from unplanned pregnancy. It is available for doctors to prescribe to women who want to take an oral contraceptive.

Estradiol valerate/ dienogest as a combined oral contraceptive (COC), works by stopping a process called ovulation. This is the process by which the ovaries release an egg. COCs are commonly used by young women to prevent pregnancy.

The researchers in this study will collect information from young women (18-35 years of age) in Russia who will start taking estradiol valerate/ dienogest.

The main purpose of this study is to find out about the women's satisfaction with taking estradiol valerate/ dienogest. To do this, the researchers will ask "how satisfied are you with the birth control method used during the study?". They will ask this question after the women have taken estradiol valerate/ dienogest for 3 and 6 months. The women willanswer this question using a rating scale ranging from 1 to 5, with 1 meaning "very dissatisfied" and 5 meaning "very satisfied".

This study will include young women (18-35 years of age) who want to use oral contraceptives and have been prescribed estradiol valerate/ dienogest by their doctor. None of the women in the study will have taken estradiol valerate/ dienogest within 1 month of joining the study.

In this study, it is expected that each woman will visit her study site 3 times. Each woman will be in the study for up to 6 months. All of the women will take estradiol valerate/ dienogest as prescribed by their doctors. There will be no other required procedures or treatments in this study which is not be used in usual practice.

During the study, the women will answer a question about how satisfied they are with estradiol valerate/ dienogest. They will also respond to some questionnaires. These will include a questionnaire about their menstrual bleeding patterns, sexual function. The doctors will:

* ask the women about any medical conditions they may have and what other contraceptives they took before they joined the study
* check the women's blood pressure and pulse rate
* ask a question about woman's intention to continue to use estradiol valerate/ dienogest and the reasons for discontinuation of estradiol valerate/ dienogest if it has happened

Conditions

  • Oral Contraception

Interventions

COMBINATION_PRODUCT

Estradiol valerate/ Dienogest

Combined hormonal contraceptive (combined oral contraceptives, COCs)

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-24
Primary Completion
2023-04-20
Completion
2023-04-20

Countries

  • Russia

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04901377 on ClinicalTrials.gov